Clinical Content Validity Guidelines
Speakers for Wright State University Boonshoft School of Medicine must assure, implicitly or explicitly, that any clinical recommendations made are valid for use in the care of patients. All scientific research referred to, reported in, or used in CME in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis. The following must be adhered to:
- Clinical care recommendations must be based on evidence that is accepted within the profession of medicine as adequate justification for their use
- All the recommendations involving clinical medicine in a CME activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients
- A recommendation on clinical care must be more than firmly held beliefs or hopes for efficacy
- Data or information accepted within the profession of medicine that supports the recommendation
- The conclusions drawn from the data must be those that would be reasonably drawn from those data
The validation of clinical content does not mean that every clinician in the country accepts the recommendation or that the recommendation is part of FDA-labeling. An important part of validity is the scientific integrity of the data from which the conclusions are drawn and the clinical recommendations crafted.